Symptomatic Articular Cartilage Defects of the Femoral Condyle including the Trochlea. osteochondritis dissecans lesions that do not require a bone graft. MedDRA version: 13.1 Level: LLT Classification code 10031231 Term: Osteochondritis dissecans System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 13.1 Level: LLT Classification code 10007705 Term: Cartilage damage System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Pharmaceutical Form: Implant
Other descriptive name: Autologous cultured human chondrocytes
Concentration type: range
Concentration number: 0.5 to 1 million-cells/cm2
Sponsors
Genzyme Europe B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: During screening: 1.Provides written informed consent, and is able to read and understand the language and content of the study material. 2.Symptomatic focal cartilage defects as defined by KOOS Pain score =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: At Screening visit: 1.Any surgery on the knee joint within 6 months prior to Screening (not including diagnostic arthroscopy). 2.Symptomatic musculoskeletal conditions in the lower limbs that could impede measurement of efficacy for the target knee joint. 3.In the target knee joint, patient requires or has a history of a total meniscectomy or meniscal allograft, or has a bucket handle tear or displaced tear that requires a meniscectomy removing >50% of the meniscus. 4.Malalignment requiring an osteotomy to correct tibial-femoral or patella–femoral alignment. Retinaculum releases are allowed if indicated to correct patella maltracking. 5.History of osteoarthritis (Kellgren-Lawrence Grade 3 or 4) in the target knee joint as diagnosed by clinically appropriate X-rays obtained at the Screening visit or within the previous 12 weeks. 6.Concomitant inflammatory disease or other condition that affects the joints (e.g., rheumatoid arthritis, metabolic bone disease, psoriasis, gout, symptomatic chondrocalcinosis). 7.History of septic arthritis in the target knee joint within 1 year prior to Screening. 8.Current malignancy or treatment for malignancy within the past 5 years, except nonmelanoma skin cancer. 9.Known history of anaphylaxis to gentamicin or any of the products used in the preparation and use of MACI implant. 10.Patients who, in the opinion of the investigator, have significant medical or psychosocial problems that warrant exclusion. Examples of significant problems include but are not limited to: Any condition that has potential for negatively impacting intra or post-operative course (including: conditions that could severely impair wound healing, e.g., peripheral vascular disease (PVD); Conditions that limit compliance with rehabilitation program, e.g., unstable or poorly controlled angina; Active infection, including unexplained fever (temperature >38.1°C) or antibiotic therapy within 1 week prior to Screening; Any condition that has potential for significantly limiting patient’s ability to assess post-operative knee function, e.g., PVD with symptomatic claudication; Any condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up, or compliance with any aspect of the study; Patient is currently abusing drugs or alcohol or, in the opinion of the investigator, at high risk for poor compliance.) 11.Previous investigational drug or device use within 3 months prior to Screening. 12.Females who are pregnant or lactating at the time of Screening (patients must agree to not become pregnant between the Screening visit and the surgical treatment visit, i.e., arthroscopy for those randomized to treatment with microfracture, and arthrotomy for those randomized to MACI implant treatment). 13.Ongoing litigation for compensation for musculoskeletal injuries or disorders. During Index Arthroscopy: 14. Modified Outerbridge Grade III or IV defect(s) located on the patella or tibia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to demonstrate superior efficacy and evaluate the safety of MACI implant compared with arthroscopic microfracture in the treatment of patients (aged 18 to 55 years old) with symptomatic articular cartilage defects of the femoral condyle including the trochlea.;Secondary Objective: ;Primary end point(s): The co-primary efficacy variable is the change from Baseline to Week 104 for the patient’s KOOS Pain and Function (Sports and Recreational Activities) scores. | — |
Countries
Czech Republic, Germany, Netherlands, Poland, Sweden, United Kingdom
Outcome results
None listed